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Behavioral Intervention

Native-CHOICES for Preventing Alcohol Exposed Pregnancies (Native-CHOICES Trial)

N/A
Recruiting
Led By Dedra Buchwald, MD
Research Sponsored by Washington State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 3 months and 6 months post intervention
Awards & highlights

Native-CHOICES Trial Summary

This trial will test whether the adapted intervention can reduce the risk of alcohol exposed pregnancies in AI/AN women.

Who is the study for?
This trial is for American Indian and Alaska Native women aged 18-44 who live on the Cheyenne River Sioux Reservation or in Rapid City, South Dakota. Participants should engage in high-risk drinking behaviors, be sexually active without effective birth control, and not currently pregnant or infertile.Check my eligibility
What is being tested?
The study tests 'Native CHOICES', an adapted intervention aimed at reducing alcohol-exposed pregnancies among participants by addressing risky alcohol use and improving contraception effectiveness.See study design
What are the potential side effects?
Since this trial focuses on behavioral intervention rather than medication, traditional drug side effects are not a concern. However, participants may experience emotional discomfort discussing personal habits like drinking and sexual activity.

Native-CHOICES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 3 months and 6 months post intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3 months and 6 months post intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reduction in alcohol exposed pregnancy

Native-CHOICES Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Native CHOICES InterventionExperimental Treatment1 Intervention
Native-CHOICES will comprise usual care plus 2 MI sessions delivered over 4 weeks; a contraception counseling session at a local clinic; and 3 months of electronic messaging to boost the effects of MI and counseling by increasing perceptions of social connection and social support for behavior change. Contraception counseling will be completed within 2 weeks after the second MI session, so the maximum duration of MI and counseling for each participant will be 6 weeks. Electronic messaging will include positive motivational content consistent with alcohol and contraception use goals set in the MI sessions.
Group II: Wait-list Control GroupActive Control1 Intervention
The control condition will comprise usual care for the 6-month study period, with a wait-list design that offers women the Native- CHOICES program after they have completed the 6-month data collection.

Find a Location

Who is running the clinical trial?

Missouri Breaks Industries Research, Inc.OTHER
7 Previous Clinical Trials
1,807 Total Patients Enrolled
Washington State UniversityLead Sponsor
101 Previous Clinical Trials
56,364 Total Patients Enrolled
University of Colorado, DenverOTHER
1,732 Previous Clinical Trials
2,143,233 Total Patients Enrolled

Media Library

Native-CHOICES (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03930342 — N/A
Native-CHOICES (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03930342 — N/A
Birth Control Research Study Groups: Native CHOICES Intervention, Wait-list Control Group
Birth Control Clinical Trial 2023: Native-CHOICES Highlights & Side Effects. Trial Name: NCT03930342 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment currently ongoing for this trial?

"Affirmative. According to data hosted on clinicaltrials.gov, the trial is currently enlisting participants and was first posted in March of 2019 before being revised in November of 2021. This medical experiment requires 350 patients from two separate sites."

Answered by AI

How many individuals are being monitored in this clinical exploration?

"Affirmative, the information on clinicaltrials.gov shows this medical investigation is currently recruiting candidates. This research initiative was first advertised on March 28th 2019 and was recently updated November 12 2021. 350 participants between two locations are mandated for inclusion in the trial."

Answered by AI

What demographic of individuals is qualified to participate in this experiment?

"For this clinical trial, 350 participants aged 18 to 44 who are on birth control will be enrolled. Additionally, the candidate must meet various criteria including being a Native American woman, self-reporting high levels of alcohol consumption in the past 90 days (such as 8+ drinks weekly or four+ drinks at once), and having engaged in intercourse with a male partner recently."

Answered by AI

Does the protocol of this experiment allow for individuals over 45 to participate?

"To be accepted into this clinical trial, participants must have passed the age of consent and not yet reached 44 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study
Dedra Buchwald 2019. "Native-Changing High-risk Alcohol Use and Increasing Contraception Effectiveness Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03930342.
~58 spots leftby Apr 2025
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